The following data is part of a premarket notification filed by Alpha Therapeutic Corp. with the FDA for Alpha Y-recipient Set.
| Device ID | K833294 |
| 510k Number | K833294 |
| Device Name: | ALPHA Y-RECIPIENT SET |
| Classification | Set, Blood Transfusion |
| Applicant | ALPHA THERAPEUTIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BRZ |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-23 |
| Decision Date | 1983-12-27 |